Boston Scientific has begun its Agent DCB STANCE trial to evaluate the safety and effectiveness of its Agent drug-coated balloon (DCB) compared to standard of care percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty—in patients with de novo (previously untreated) coronary lesions.

STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study of over 1,600 patients. Its primary endpoint is defined as target lesion failure (TLF) at 12 months.

Boston Scientific said in addition to assessing de novo small vessel treatment with Agent DCB, the trial will be notable for examining use of the device in patients with bifurcations and long lesions.

The Agent DCB, which received U.S. Food and Drug Administration (FDA) approval in March 2024, is the only drug-coated balloon approved in the U.S. and is currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. Traditional therapies to treat ISR in the U.S. included placing additional layers of metal stents, uncoated balloon angioplasty, and radiation—all of which might not provide ideal outcomes in some cases.

Data from the AGENT IDE clinical trial showed the Agent DCB was superior to uncoated balloon angioplasty for the primary endpoint of target lesion failure at 12 months.

“This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “Positive results from this trial will support an expanded indication of the AGENT DCB in the U.S. and help interventional cardiologists determine the optimal treatment strategy for patients living with coronary artery disease.”